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Omentectomy vs Omental Preservation in Resectable Cancer

Non-inferiority Randomized Clinical Trial Comparing Omenectomy and Omental Preservation in Resectable Gastric Cancer

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05747482
Enrollment
569
Registered
2023-02-28
Start date
2024-01-01
Completion date
2031-07-01
Last updated
2023-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of Stomach

Brief summary

European clinical guidelines do not establish a clear recommendation neither for nor against omentectomy of this segment, the American clinical guidelines recommend omentectomy in view of its potential long-term oncological benefit, and Japanese clinical guidelines only recommend 2nd segment omentectomy in locally advanced gastric cancers (stage T3-T4) recommending omental preservation in early gastric cancers (stage T1-T2). Faced with this lack of consensus, we propose a randomized, prospective and multicentric study in patients with resectable gastric cancer in stage T3-4 N+/- M0. Patients will be randomized into two groups, one where omentectomy of the 2nd omental portion will be performed and another where omental preservation will be performed. The aim of our study is to analyze the disease-free interval and survival between both groups, also comparing postoperative complications and mortality.

Interventions

OTHERSurgery procedure

Omentectomy vs omental preservations during gastric surgery

Sponsors

Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Older than 18 years old * Resectable gastric cancer * Gastric cancer T3-4 N+/- M0

Exclusion criteria

* M1 * Non surgical patients for medical status * Non resectable gastric cancer during surgery * Endoscopic resectable gastric cancer

Design outcomes

Primary

MeasureTime frameDescription
disease free interval5 yearstime between surgery and recurrence. Units of measure: months

Secondary

MeasureTime frameDescription
global survival5 yearssurvival between surgery and last follow-up date. Units of measure: percentage
survival at 5 years5 yearssurvival between surgery and 5 years. Units of measure: percentage
complications - CCI30 days after surgerytype of complications and CCI number. Units of measure: enter number between 1 and 100
postoperatory mortality30 days after surgerymortality after surgery. Units of measure: percentage

Contacts

Primary ContactSandra Montmany, PhD
smontmany@tauli.cat937231010
Backup ContactAndrea Torrecilla, MD
atorrecillaportoles@gmail.com937231010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026